Pfizer Inc. v. Teva Pharmaceuticals USA, Inc., 803 F.Supp.2d 409 (2011)
`80 Fed.R.Serv.3d 966
`
`KeyCite Yellow Flag - Negative Treatment
`Judgment Amended by
` Pfizer Inc. v. Teva Pharmaceuticals USA, Inc.,
`E.D.Va.,
`September 30, 2011
`
`
`
`803 F.Supp.2d 409
`United States District Court,
`E.D. Virginia,
`Norfolk Division.
`
`PFIZER INC., Pfizer Ltd., and Pfizer Ireland
`Pharmaceuticals Unlimited Liability Co.,
`Plaintiffs and Counterclaim Defendants,
`v.
`TEVA PHARMACEUTICALS USA, INC.,
`Defendant and Counterclaim Plaintiff.
`
`Ordered accordingly.
`
`Attorneys and Law Firms
`
`*413 Conrad M. Sumadine, Esq., Willcox & Savage PC,
`Norfolk, VA, Daniel P. DiNapoli, Esq., Aaron Stiefel, Esq.,
`Soumitra Deka, Esq., Steven J. Glassman, Kaye Scholer LLP,
`New York, NY, for Plaintiffs.
`
`Gregory N. Stillman, Esq., Hunton & Williams, Norfolk,
`VA, Kevin J. Culligan, Esq., Keith A. Zullow, Esq., John
`P. Hanish, Esq., Goodwin Procter LLP, New York, NY, for
`Defendant.
`
`Civil No. 2:10cv128.
`
` | Aug. 12, 2011.
`
`OPINION AND FINAL ORDER
`
`Synopsis
`Background: Holder of patent claiming use of certain
`chemical compounds as method of
`treating erectile
`dysfunction brought action against competitor, alleging
`imminent infringement. Competitor counterclaimed, seeking
`declaration that competitor's planned drug would not infringe
`patent and that patent claims were invalid.
`
`Holdings: Following bench trial, the District Court, Rebecca
`Beach Smith, J., held that:
`
`[1] patent assignee had standing to sue for infringement of
`patent;
`
`licensee
`[2]
`infringement;
`
`lacked standing
`
`to sue competitor for
`
`[3] amendment to competitor's complaint during trial to
`include inequitable conduct claim would prejudice counsel
`and patent holder;
`
`[4] patent was not invalid based on obviousness;
`
`[5] patent was not invalid for obviousness-type double
`patenting; and
`
`[6] attorney's failure to produce statement of claim to Patent
`and Trademark Office (PTO) did not constitute inequitable
`conduct.
`
`REBECCA BEACH SMITH, District Judge.
`
`On March 24, 2010, Pfizer, Inc., Pfizer, Ltd., and
`Pfizer Ireland Pharmaceuticals Partnership 1 (collectively
`“Pfizer”) 2 filed *414 suit in this court against Teva
`Pharmaceuticals USA, Inc. (“Teva”) 3 alleging imminent
`infringement of Pfizer's United States Patent No. 6,469,012
`(“the ′012 patent”), entitled “Pyrazolopyrimidinones for the
`Treatment of Impotence.” United States Patent No. 6,469,012
`(filed May 13, 1994) (issued Oct. 22, 2002), Plaintiff's Exhibit
`(hereinafter referred to as “PTX”) 0001. The ′012 patent
`claims the use of certain chemical compounds as a method of
`treating erectile dysfunction (“ED”). Only Claims 25 and 26
`of the ′012 patent are in dispute in this case. See Pfizer, Inc. v.
`Teva Pharms. USA, Inc., No. 2:10cv128, 803 F.Supp.2d 459,
`463–64, 2011 WL 3610654 (E.D.Va. Jan. 18, 2011) (noting
`that only these claims are at issue in this case), Docket # 77. 4
`
`One of the especially preferred compounds of the ′012 patent
`is sildenafil, the active ingredient in the ED drug Viagra. 5
`On October 25, 2004, Teva filed an Abbreviated New Drug
`Application with the Food and Drug Administration (“FDA”)
`seeking approval to market a generic equivalent of Viagra
`containing sildenafil citrate. See PTX 238. On April 24, 2007,
`the FDA granted Teva tentative approval to do so. 6 Pfizer
`alleges in its Amended Complaint that Teva's planned generic
`drug will infringe the ′012 patent, and seeks a declaration
`from the court to that effect.
`
` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
`
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`AstraZeneca Exhibit 2034
`Lannett v. AstraZeneca
`IPR2015-01629
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`

`
`Pfizer Inc. v. Teva Pharmaceuticals USA, Inc., 803 F.Supp.2d 409 (2011)
`80 Fed.R.Serv.3d 966
`
`On April 29, 2010, Teva answered the Complaint and filed a
`Counterclaim against Pfizer seeking a declaration that Teva's
`planned drug will not infringe the ′012 patent and that the
`claims of the ′012 patent are invalid. Teva subsequently
`sought, and was granted, leave of the court to file an Amended
`Answer and Counterclaim, which amendment added an
`allegation that the ′012 patent is invalid because of inequitable
`conduct committed during its prosecution before the Patent
`and Trademark Office (“PTO”). 7 On December 13, 2010,
`this court held a hearing pursuant to Markman v. Westview
`Instruments, Inc., 517 U.S. 370, 372, 116 S.Ct. 1384, 134
`L.Ed.2d 577 (1996), and issued an opinion on March 17,
`2011, construing the disputed terms of the patent. See *415
`Pfizer, Inc. v. Teva Pharms. USA, Inc., 803 F.Supp.2d 397,
`2011 WL 996794 (E.D.Va.2011).
`
`A bench trial in this case commenced on June 15,
`2011, lasting for twelve days. At trial, Teva stipulated to
`infringement, and therefore this issue is not before the court.
`See Docket # 330. On July 17, 2011, after final arguments
`had concluded, this court took all outstanding issues under
`advisement. This Opinion and Final Order addresses and
`resolves all remaining motions and merits determinations.
`
`I. Factual Overview
`
`The patent in suit in this case is the ′012 patent, and in
`particular Claims 25 and 26, which claim:
`
`25. A method of treating erectile dysfunction in a male
`human, comprising orally administering to a male human
`in need of such treatment an effective amount of a
`compound selected from:
`
`[listing nine different chemical compounds]
`
`or a pharmaceutically acceptable salt thereof;
`
`or a pharmaceutical composition containing either
`entity.
`
`26. A method as defined
`in claim 25, wherein
`said compound
`is [listing a chemical compound]
`or a pharmaceutically acceptable salt thereof, or a
`pharmaceutical composition containing either entity.
`
`′012 patent col. 10, lines 1–39, PTX 0001. 8 Thus, these
`claims of the patent teach the oral administration of sildenafil
`and other compounds for the treatment of ED. 9 The ′012
`
`patent will expire on October 22, 2019. See Final Pretrial
`Order ¶ 9, Docket # 267. 10
`
`As the patent in suit concerns the treatment of ED, bringing
`with it a host of technical terminology and a background
`of underlying knowledge, this court will first review the
`biology and physiology of erections 11 and then will move to
`a description of the invention and patents concerned.
`
`A. 12
`
`The penis of a male human contains erectile tissue called
`the corpus cavernosum, consisting of two corpora cavernosa
`that run its length. The corpus cavernosum is smooth muscle
`tissue that is spongy and composed of cavernosal spaces
`which *416 can expand and fill with blood to produce an
`erection. The corpus cavernosum is surrounded by fibrous
`tissue known as the tunica albuginea. When the penis is
`in a flaccid state, the corpus cavernosum is contracted. An
`erection is produced when the corpus cavernosum relaxes so
`that it expands and fills with blood. As the corpus cavernosum
`relaxes, the tunica albuginea compresses the veins that drain
`blood from the penis, thus preventing blood from flowing
`out and raising pressure inside the penis, producing an
`erection. Detumescence of the penis occurs when the corpus
`cavernosum contracts and bloods flows out of the penis.
`
`An erection is controlled by the nervous system. There
`are three neurotransmission pathways in the human body:
`the adrenergic nerves; the cholinergic nerves; and the non-
`adrenergic, non-cholinergic (“NANC”) nerves. The NANC
`nerves control erectile function. When a male human reacts
`to sexual stimuli, the NANC nerves send a signal to the penis.
`The neurotransmitter in this case is nitric oxide (“NO”). 13
`Thus, when the NANC nerves send a signal to the penis,
`they synthesize NO from L-arginine in the endothelial cells of
`the vascular system. The NO travels into the smooth muscle
`cells of the corpus cavernosum where it activates an enzyme
`known as guanylate cyclase. Guanylate cyclase synthesizes
`another enzyme, cyclic guanosine monophosphate (“cGMP”)
`by interacting with guanosine triphosphate. cGMP is the
`signaling enzyme that cues smooth muscle tissue, in this case
`the corpus cavernosum, to relax. 14 This entire process is
`known as the L-arginine-nitric oxide-cyclic GMP pathway.
`
`cGMP is a cyclic nucleotide, a form of enzyme. Enzymes,
`as is evident from cGMP's function in the smooth muscle
`
` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
`
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`

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`Pfizer Inc. v. Teva Pharmaceuticals USA, Inc., 803 F.Supp.2d 409 (2011)
`80 Fed.R.Serv.3d 966
`
`described above, are proteins that catalyze chemical reactions
`in the body. cGMP is degraded by cGMP phosphodiesterase
`(“PDE”), another enzyme, which binds to cGMP and breaks it
`down into GMP. GMP does not have the same signaling effect
`in smooth muscle as cGMP. At the time the ′012 patent was
`filed, there were five known types of PDEs: PDE1, PDE2,
`PDE3, PDE4, and PDE5. PDE1 and PDE5 both degrade
`cGMP and, thus, are termed cGMP PDEs. 15
`
`cGMP PDE can be inhibited by cGMP PDE inhibitors. An
`inhibitor functions in the same was that cGMP PDE itself
`functions with cGMP, by binding to it to block or decrease the
`activity of the enzyme. In other words, cGMP PDE inhibitors
`bind to cGMP PDE so that it, in turn, cannot bind to cGMP.
`The effectiveness of a PDE inhibitor is measured in terms of
`its potency, the amount of the inhibitor required to effectively
`inhibit the PDE, 16 and its selectivity, i.e., the ratio at which
`the inhibitor prefers one PDE over another. 17
`
`*417 B.
`
`Beginning in 1985, Pfizer researchers in Sandwich, England
`were working on the creation of cGMP PDE inhibitor drugs
`to treat cardiovascular diseases such as hypertension and
`angina. Dr. Peter Ellis was the head of the team of biologists
`on the project, while Dr. Nicholas Terrett led the chemists.
`Pfizer hoped that cGMP PDE inhibitors would be able to treat
`these cardiovascular diseases by-causing relaxation of the
`smooth muscle tissue in the arteries, thereby lessening stress
`on the cardiovascular system. In particular, Pfizer aimed to
`create compounds that would inhibit cGMP PDEs, thereby
`enhancing the action of cGMP within smooth muscle and
`causing smooth muscle relaxation.
`
`The project first started with the chemistry team creating
`compounds. Such compounds were based off other
`compounds known to inhibit cGMP PDE, and the chemistry
`team worked to make such compounds more selective, in
`terms of which enzyme they inhibited, and more potent
`in their inhibitory capability. 18 Once the compounds were
`made, the biology team tested the compounds in assays
`it designed to determine their selectivity and potency for
`cGMP PDE. The chemistry team then received feedback
`and modified the compounds further, if necessary, to
`improve their biological activity. The chemistry team also
`ran tests to assess the safety of the compounds, while the
`pharmacokinetic team studied the compounds to determine
`
`their absorption, distribution, metabolism, and excretion in
`the human body.
`
`The chemistry team first synthesized sildenafil in 1989, and
`it quickly became a “lead compound,” after the biology
`and pharmacokinetic tests had been run. 19 The results
`were so encouraging that the team working on the project
`recommended that Pfizer begin clinical development of
`sildenafil for the treatment of angina. See PTX 354. A
`year later, in July 1991, Pfizer began its first clinical trial
`using sildenafil, Study 201. Trial Tr. 695:21–697:14. As this
`clinical trial was a Phase I study, the subjects were healthy
`volunteers, in this case males, and the goal was to assess the
`safety of the drug and further determine its pharmacokinetic
`properties. This initial study, and several others after it, all
`tested single doses of sildenafil.
`
`In 1992, Pfizer began a multiple dose study of sildenafil,
`again using healthy male volunteers, Study 207. Trial
`Tr. 697:21–699:9. The volunteers were administered three
`doses of sildenafil or a placebo daily for ten days. At the
`conclusion of the study, volunteers reported several side
`effects; the most common were myalgia, 20 headaches, and
`spontaneous erections. The Early Candidate Management
`Team (“ECMT”), the team charged with the initial testing
`and development of sildenafil that included Dr. Ellis, was
`surprised to hear that a common side effect was spontaneous
`erections, as such a side effect had never been previously
`reported in Pfizer clinical trials. As a result of this report from
`the volunteers, the ECMT decided to run a clinical trial with
`sildenafil directed toward the treatment of ED.
`
`The first Phase II clinical study with sildenafil, Study 350,
`began on July 28, 1993, and concluded on November 15,
`1993. See PTX 471. As it was a Phase II *418 study, its
`volunteers were males with the targeted disease, i.e., men who
`suffered from ED. The volunteers were orally administered
`either sildenafil or a placebo three times a day for seven
`days. They recorded any erectile activity experienced during
`the first six days. On the seventh day, while each volunteer
`was provided sexual stimulation by watching an erotic video,
`rigidity and circumference of his penis was measured using
`a Rigiscan. 21 The results showed that sildenafil significantly
`improved erections for those men in the test with ED.
`
`Pfizer then commenced a single dose Phase II study, Study
`351, on February 24, 1994, concluding May 30, 1994. Trial
`Tr. 706:21–707:20. In this study, male volunteers with ED
`were given a single dose of sildenafil on one occasion, and
`
` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Pfizer Inc. v. Teva Pharmaceuticals USA, Inc., 803 F.Supp.2d 409 (2011)
`80 Fed.R.Serv.3d 966
`
`a Rigiscan was administered. The same volunteers were then
`given sildenafil once a day for seven days, and they made note
`of their erectile activity. The results were encouraging and
`showed a correlation between the administration of sildenafil
`and improved erectile function for men with ED.
`
`Pfizer next filed European Patent Number 0526004A1 (“EP
`#004”), also entitled “Pyrazolopyrimidinone Antianginal
`Agents,” on February 7, 1992. EP ′ 004 was published on
`March 2, 1993. PTX 0066. EP ′004 claimed additional potent
`and selective cGMP PDE inhibitors useful in the treatment of:
`
`Based on the results of the studies described, Pfizer applied
`to the FDA for approval of Viagra, sildenafil citrate. Viagra
`was approved by the FDA in 1998 in New Drug Application
`No. 20–895 as a drug to treat ED. Viagra works, as the ′012
`patent states, because it is a PDE5 inhibitor that prevents
`PDE5 from binding to cGMP and rendering cGMP inactive
`in the L-arginine-nitric oxide-cyclic GMP pathway, thus
`increasing the level of cGMP in the corpus cavernosum.
`Viagra's introduction on the market in 1998 generated a flurry
`of publicity and interest from scientists and consumers alike.
`Experts from both parties admitted that Viagra revolutionized
`the treatment of ED, making the treatment both more effective
`and accessible. Since its introduction in 1998, Viagra has
`generated cumulative sales of over $10 billion.
`
`C.
`
`After successfully creating sildenafil and other related
`compounds, Pfizer filed a series of applications for patents. 22
`Initially, Pfizer filed several compound patents. The first was
`European Patent Number 0463756A1 (“EP '756”) entitled
`“Pyrazolopyrimidinone Antianginal Agents,” filed June 7,
`1991, and published February 1, 1992. PTX 0352. EP
`′756 first disclosed sildenafil, among other compounds,
`and claimed such compounds as selective cGMP PDE
`inhibitors 23 which elevate the levels of cGMP. See EP ′756,
`3:5–7, PTX 0352. The specification of the patent discloses:
`
`[T]he compounds have utility in the treatment of a
`number of disorders, including stable, unstable and
`variant (Prinzmetal) angina, hypertension, congestive heart
`failure, atherosclerosis, conditions of reduced blood vessel
`patency e.g. postpercutaneous
`transluminal coronary
`angioplasty (post-PTCA), peripheral vascular disease,
`stroke, bronchitis, chronic asthma, allergic asthma, allergic
`rhinitis, glaucoma, and diseases *419 characterized by
`disorders of gut motility, e.g. irritable bowel syndrome
`(IBS).
`EP ′756, 3:9–14, PTX 0352. Of the compounds in Claims
`25 and 26 of the patent in suit, EP ′756 disclosed five,
`including sildenafil. 24
`
`variant
`and
`unstable
`[S]table,
`(Prinzmetal) angina, hypertension,
`pulmonary hypertension, congestive
`heart
`failure,
`atherosclerosis,
`conditions
`of
`reduced
`blood
`vessel patency e.g. postpercutaneous
`transluminal coronary angioplasty
`(post-PTCA), peripheral vascular
`disease, stroke, bronchitis, chronic
`asthma, allergic asthma, allergic
`rhinitis, glaucoma, and diseases
`characterized by disorders of gut
`motility, e.g. irritable bowel syndrome
`(IBS).
`
`EP ′004, 2:10–14, PTX 0066. EP ′004 disclosed four of the
`compounds in Claim 25 of the ′012 patent. 25
`
`Finally, Pfizer filed United States Patent Number 5,250,534
`(“the ′534 patent”) on May 14, 1992. PTX 0002. The
`′534 patent is the U.S. equivalent of EP ′756 and, thus, is
`also entitled “Pyrazolopyrimidinone Antianginal Agents” and
`shares the same specification and characteristics of EP ′756
`described above, including the diseases the compounds were
`believed to be useful in treating. The ′534 patent likewise
`covers five of the compounds listed in Claims 25 and 26 of
`the ′012 patent, including sildenafil. The ′534 patent issued
`on October 5, 1993. 26 Each of these compound patents
`—EP ′756, EP ′004, and the ′534 patent—disclosed oral
`administration of the relevant compounds.
`
`After Pfizer had filed the compound patents for sildenafil
`and the other cGMP PDE inhibitors, it filed the patent
`in suit directed to a method of treating ED using some
`of the compounds from EP ′756 and EP ′004. Claims 25
`and 26 specifically claim oral treatment of ED, and the
`specification of the patent states that oral administration is
`the preferred route. ′012 patent, col. 5, lines, 62–65, PTX
`0001. 27 In the specification of the patent, Pfizer discloses
`that the compounds of the ′012 patent have been found to
`be potent and selective inhibitors of PDE5 such that they
`enhance cGMP levels in the corpus cavernosum. Id. col. 5,
`
` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
`
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`

`
`Pfizer Inc. v. Teva Pharmaceuticals USA, Inc., 803 F.Supp.2d 409 (2011)
`80 Fed.R.Serv.3d 966
`
`lines 33–35, 39–44, PTX 0001. 28 The ′012 patent issued,
`after overcoming numerous rejections, on October 22, 2002.
`
`With the pertinent factual underpinnings of the case set out,
`this court turns to the substantive issues remaining before it.
`
`II. Teva's Motion to Dismiss for Lack of Standing
`
`During trial on July 6, 2011, Teva filed a Motion to Dismiss
`for Lack of Standing. *420 See Docket # 412. Teva argues
`that Pfizer has failed to carry its burden to demonstrate that
`each plaintiff has standing to sue for infringement of the
`patent in suit because it has failed to prove that any plaintiff
`has sufficient interest in the patent to sue for infringement.
`Per a briefing schedule set by the court, Pfizer responded in
`opposition on July 15, 2011, see Docket # 435, and Teva
`replied on July 20, 2011, see Docket # 451. The motion is
`now ripe for decision.
`
`A.
`
`The issue of standing in this case is bound up with the
`evidence on the issue of ownership, 29 and thus the court
`reviews the evidence as to both presented at trial. 30 Looking
`first to the patent in suit itself, Pfizer, Inc. is named as the
`owner-assignee on the face of the ′012 patent. PTX 0001.
`Pfizer, Inc. received the assignment of rights to the patent
`from the patent's inventors, Drs. Nicholas Terrett and Peter
`Ellis, on October 10, 1995. PTX 0363. In the assignment, Drs.
`Terrett and Ellis agreed to:
`
`....
`[S]ell, assign, and transfer unto PFIZER, INC
`the entire right, title, and interest in and to our
`application for Letters Patent of the United States ...
`entitled PYRAZOLOPYRIMIDINONES FOR THE
`TREATMENT OF IMPOTENCE and our entire right, title,
`and interest in the United States in and to all our inventions,
`whether joint or sole, disclosed in said application for
`Letters Patent, and in all and to all United States patents
`granted on the foregoing inventions.
`Id. at 1. On the same day, Pfizer, Ltd., whose employment
`of Drs. Terrett and Ellis entitled it to claim full rights
`to the patentable inventions, consented to the assignment,
`noting that “PFIZER LIMITED desires that PFIZER INC.
`
`receive the full benefits of the foregoing assignment by its
`aforesaid employee(s).” Id. at 3.
`Previously on August 9, 1993, Pfizer, Inc. and Pfizer, Ltd.
`entered into a Patent Filing Agreement. PTX 0322. The
`Patent Filing Agreement memorialized “the procedures to be
`applied in respect of the filing of patent applications resulting
`from research carried out under the Cost Sharing Agreement
`[between Pfizer, Inc. and Pfizer, Ltd.] and the procedure
`applicable to patent applications resulting from other research
`carried on by LIMITED.” Id. at 2. Specifically:
`
`patent
`Property
`LIMITED
`applications will be filed by PFIZER
`[INC.] in the USA.... In filing such
`applications, PFIZER [INC.] will act
`as agent for LIMITED, so that such
`applications and any patents issued
`thereon shall be held *421 by
`PFIZER [INC.] in trust for LIMITED,
`as the beneficial owner thereof.
`
`Id. at 3–4. In addition, to effectuate the filing of patents,
`Pfizer, Ltd. agreed that it would be “deemed to assign PFIZER
`[INC.] ... all rights necessary ... to file patent applications
`hereunder.” Id. at 5. In consideration for its filing of the patent
`applications, Pfizer, Inc. could receive from Pfizer, Ltd. “a
`non-exclusive license ... with respect to any such LIMITED
`Property in the USA.” Id. at 6.
`
`After the application for the ′012 patent was filed, but
`before it was issued by the PTO, Pfizer, Ltd. executed a
`license agreement with Pfizer Pharmaceuticals Production
`Corporation, effective as of January 1, 1997. PTX 0324.
`The license agreement concerned patents for sildenafil,
`either issued or currently pending, including both the ′534
`patent and the ′012 patent. Id. at 13. Therein, Pfizer, Ltd.
`granted to Pfizer Pharmaceuticals Production Corporation
`“(1) an exclusive license under the U.S. Patent Rights to
`make, use, sell, and offer for sale Licensed Product in the
`Commercial Territory, and to import Licensed Product into
`the Commercial Territory and (2) an exclusive license to
`use the Technical Information in the Commercial territory in
`connection with the activities referred to [above].” Id. at 4.
`“Commercial Territory” was defined as the United States of
`America, id. at 2, and “Licensed Product” was defined as “any
`drug for human use containing the Compound, [sildenafil].”
`Id. at 3. Thus, Pfizer Pharmaceuticals Production Corporation
`received, in essence, an exclusive license to manufacture and
`sell sildenafil in the United States. This exclusive license was
`subject to Pfizer, Ltd.'s retained “Conversion Right,” the right
`
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`80 Fed.R.Serv.3d 966
`
`“to convert the exclusive license granted ... to a non-exclusive
`license” at any time when at least 20% remains on the patent
`term. Id. at 2–4. In return for the exclusive license, Pfizer
`Pharmaceuticals Production Corporation would pay Pfizer,
`Ltd. royalties based on net sales in a schedule set out in
`the agreement. Id. at 6. In the case of infringement of any
`of the patents covered by the agreement, Pfizer, Ltd. had
`“the initial right to bring suit in its own name” with Pfizer
`Pharmaceuticals Production Corporation's cooperation, but
`if Pfizer, Ltd. failed to bring suit within thirty (30) days,
`Pfizer Pharmaceuticals Production Corporation could bring
`suit in its own name, joining Pfizer, Ltd. and Pfizer, Inc. as
`necessary. Id. at 7–8.
`
`The license agreement for sildenafil has since “changed
`hands” several times due to changes in ownership of the entity
`holding it. First, on January 15, 1998, Pfizer Pharmaceuticals
`Production Corporation entered into a Sale Agreement
`with Pfizer Pharmaceuticals Production Corporation, Ltd.
`for the “entire Irish business and Irish assets of Pfizer
`Pharmaceuticals Production Corporation.” PTX 0325, at
`1. As part of the Sale Agreement, Pfizer Pharmaceuticals
`Production Corporation transferred all of its assets, including
`all licenses. Id. at 2, 4. The license for sildenafil was
`specifically noted as one of the licenses that would transfer to
`the new entity. Id. at 13.
`
`Pfizer
`2000,
`14,
`on November
`Subsequently,
`Pharmaceuticals Production Corporation, Ltd. entered into
`an “Agreement for Sale of Business and Assets” with
`Pfizer Ireland Pharmaceuticals. PTX 0326. Again, as
`part of this Agreement for Sale, Pfizer Pharmaceuticals
`Production Corporation, Ltd. transferred to Pfizer Ireland
`Pharmaceuticals all assets, id. at 4, including contracts and
`agreements, id. at 5, one of which was the license agreement
`for sildenafil. Id. at 10.
`
`The license was transferred yet again on November 28,
`2003, via an “Agreement for Sale of Business and Assets”
`between Pfizer Ireland Pharmaceuticals and Pfizer Ireland
`*422 Pharmaceuticals Partnership. PTX 0209. Pfizer
`Ireland Pharmaceuticals agreed to transfer to Pfizer Ireland
`Pharmaceuticals Partnership all of its assets and business,
`including contracts. Id. at 5. Contracts was defined to
`include all license agreements undertaken by Pfizer Ireland
`Pharmaceuticals. Id. at 2. This Agreement for Sale did not,
`however, list the particular licenses to be transferred.
`
`Finally, on January 10, 2011, Pfizer Ireland Pharmaceuticals
`Partnership sold all of
`its assets
`to Pfizer Ireland
`Pharmaceuticals Unlimited Liability Co. (“Pfizer Ireland
`Pharmaceuticals Co.”). PTX 0210. Pfizer
`Ireland
`Pharmaceuticals Partnership agreed to transfer all of its
`assets, including its interest in contracts, id. at 7, which
`was defined to include all license agreements. Id. at 2.
`Again, there was no schedule listing the specific license
`agreements transferred. Pfizer Ireland Pharmaceuticals Co.
`currently holds the license for sildenafil in the United States.
`
`B.
`
` [3]
` [2]
`[1]
` Standing is a jurisdictional requirement for
`any federal case and may never be waived by the parties.
`E.g., Sicom Systems, Ltd. v. Agilent Techs., Inc., 427 F.3d
`971, 975 (Fed.Cir.2005); Pandrol USA, L.P. v. Airboss Ry.
`Prods., Inc., 320 F.3d 1354, 1367 (Fed.Cir.2003) (“It is well-
`established that any party, and even the court sua sponte, can
`raise the issue of standing for the first time at any stage of
`the litigation, including on appeal.”). The party asserting the
`infringement has the burden to prove that it has standing to
`do so. Mentor H/S, Inc. v. Med. Device Alliance, Inc., 240
`F.3d 1016, 1017 (Fed.Cir.2001) (per curiam). In patent cases,
`the law of standing has its sources both in constitutional law
`and the Patent Act. Beam Laser Sys., Inc. v. Cox Commc'ns,
`Inc., 117 F.Supp.2d 515, 520 (E.D.Va.2000). The Patent
`Act provides: “A patentee shall have remedy by civil action
`for infringement of his patent.” 35 U.S.C. § 281 (2006).
`“Patentee” is defined under the Act to include “not only
`the patentee to whom the patent was issued but also the
`successors in title to the patentee.” Id. at § 100; see also
`Morrow v. Microsoft, 499 F.3d 1332, 1339 (Fed.Cir.2007)
`(“The ‘successor[ ] in title’ is the party holding legal title to
`the patent.” (emphasis in original)). Beyond the requirement
`that a plaintiff must be a “patentee” under the statute to sue
`for infringement, there is also the constitutional requirement
`that the party alleging infringement show an injury-in-fact.
`Morrow, 499 F.3d at 1339.
`
` [5]
`[4]
` The Federal Circuit has held that there are three
`types of parties for standing purposes as concerns patents:
`“those that can sue in their own name alone; those that can sue
`as long as the patent owner is joined in the suit; and those that
`cannot even participate as a party to an infringement suit.” Id.
`There are three entities that meet the requirements for the first
`category. It is clear from the statute that the patentee, owner of
`the patent, is a party that may sue on its own for infringement.
`
` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
`
`6
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`Pfizer Inc. v. Teva Pharmaceuticals USA, Inc., 803 F.Supp.2d 409 (2011)
`80 Fed.R.Serv.3d 966
`
`35 U.S.C. § 281; Sicom, 427 F.3d at 976. Additionally, if a
`patentee assigns its rights in a patent, the assignee may sue
`for infringement in its own name, Sicom, 427 F.3d at 976, as
`the assignee has legal title to the patent. Morrow, 499 F.3d
`at 1339. Finally, an exclusive licensee who has all substantial
`rights in the patent is treated like an assignee for the purposes
`of standing. Sicom, 427 F.3d at 976. The court must look to
`the license agreement to determine if the licensee in fact holds
`all substantial rights. Ortho Pharm. Corp. v. Genetics Inst.,
`Inc., 52 F.3d 1026, 1030 (Fed.Cir.1995).
`
` [7]
`[6]
` The second category, parties who may sue if the
`owner of the patent is joined, includes exclusive licensees
`that do *423 not have all substantial rights in the patent.
`Indep. Wireless Tel. Co. v. Radio Corp. of Am., 269 U.S. 459,
`468, 46 S.Ct. 166, 70 L.Ed. 357 (1926); Sicom, 427 F.3d at
`980; Abbott Labs. v. Diamedix Corp., 47 F.3d 1128, 1132
`(Fed.Cir.1995). “An exclusive licensee receives more rights
`than a nonexclusive licensee, but fewer than an assignee. An
`example of an exclusive licensee is a licensee who receives
`the exclusive right to practice an invention but only within
`a given limited territory.” Sicom, 427 F.3d at 976 (citing
`Rite–Hite Corp. v. Kelley Co., Inc., 56 F.3d 1538, 1552
`(Fed.Cir.1995)). Thus, crucial to the determination of whether
`an entity is an exclusive licensee is whether the licensee
`holds exclusionary rights to the patent, the right to “prevent
`others from practicing the invention.” Morrow, 499 F.3d at
`1340. “To have co-plaintiff standing in an infringement suit,
`a licensee must hold some of the proprietary sticks from the
`bundle of patent rights, albeit a lesser share of rights in the
`patent than for an assignment and standing to sue alone.”
`Ortho Pharm., 52 F.3d at 1031. In other words, to have
`standing at all, a licensee must have “beneficial ownership of
`some of the patentee's proprietary rights.” Id. at 1034. Again,
`the court looks to the license agreement to determine if a
`licensee is an exclusive licensee.
`
`[8]
` The final type of entity for standing purposes is a
`nonexclusive licensee that cannot even join an infringement
`suit. The Federal Circuit has been clear that “[a] holder of
`such a nonexclusive license suffers no legal injury from
`infringement and, thus, has no standing to bring suit or even
`join in a suit with the patentee.” Ortho Pharm., 52 F.3d
`at 1031. Nonexclusive licensees are “those that hold less
`than all substantial rights to the patent and lack exclusionary
`rights under the patent statutes to meet the injury-in-fact
`requirement.” Morrow, 499 F.3d at 1340. Such entities do
`not meet the statutory or constitutional requirements of
`
`standing and may not join with other parties in pursuing an
`infringement suit.
`
`The three categories of plaintiffs enumerated above are well-
`settled in Federal Circuit precedent for establishing standing
`in suits at law for damages. Moreover, there is one other
`type of entity that may have standing to sue in equity,
`in other words for injunctive relief. In Arachnid, Inc. v.
`Merit Industries, Inc., 939 F.2d 1574 (Fed.Cir.1991), the
`Federal Circuit distinguished between entities with standing
`in law and entities with standing in equity. It held that when
`an entity has equitable ownership of a patent, that entity
`may seek only prospective relief in equity, not damages
`for infringement. Id. at 1579. A party “seeking to recover
`money damages for infringement of a United States patent
`(an action ‘at law’) must have held the legal title to the
`parent during the time of the infringement.” Id. (emphasis
`omitted). Conversely, if a party only has equitable title, “a
`federal district court has jurisdiction to consider claims for
`equitable relief stemming from the alleged infringement.” Id.
`at 1580 (emphasis omitted). This court has recognized the
`Federal Circuit precedent supporting the conclusion that a
`party having equitable title to a patent may sue in equity to
`prevent further infringements. Beam Laser, 117 F.Supp.2d at
`520. With these legal underpinnings, the court turns to the
`standing issue raised by Teva.
`
`C.
`
` Teva argues that all of the remaining Pfizer entities 31
`[9]
`lack standing to sue *424 for infringement of the patent. For
`the sake of clarity, the court will consider each of the parties
`individually. 32 First, Teva argues that Pfizer has failed to
`pro